Silarx Lamivudine Recall: Mismatched Expiration Dates
Silarx recalls Lamivudine Oral Solution due to incorrect expiration dates on cartons vs. bottles. Check your lot and dates immediately.
Use caution until it’s fixed
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Contact the company
What happened, in plain English
Silarx Pharmaceutical, Inc. is recalling Lamivudine Oral Solution because the expiration date printed on the unit carton does not match the date on the bottle label. This specific issue involves Lot #0649A, where the carton shows an expiration of 05/18 but the bottle label shows 05/17. The company received a customer complaint regarding this discrepancy before initiating the recall. Read more at govinfonow.com/recall/43818-silarx-pharmaceutical-inc-recalls-lamivudine-oral-solution-usp-10-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/43818-silarx-pharmaceutical-inc-recalls-lamivudine-oral-solution-usp-10-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1416-2015
Cite this page
“Silarx Lamivudine Recall: Mismatched Expiration Dates.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43818-silarx-pharmaceutical-inc-recalls-lamivudine-oral-solution-usp-10-mg. Based on FDA recall #D-1416-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1416-2015%22&limit=1).
Why it’s dangerous
The hazard is a labeling error where the expiration dates do not match between the outer carton and the inner bottle. This creates confusion about when the medication expires, potentially leading patients to use a drug that may have expired earlier than the carton suggests or discard a safe product prematurely.
Who’s affected
Patients who have been prescribed Lamivudine Oral Solution and possess bottles from Lot #0649A are affected. Individuals using this medication for HIV treatment or chronic hepatitis B may be at risk if they rely on the incorrect date to determine potency.
How to tell if you have this one
Look for Lamivudine Oral Solution, USP, 10 mg per 1 mL in a 240 mL (8 ounces) bottle. Check the NDC number 54838-0566-70 and specifically verify if the lot number is 0649A. Confirm that the expiration date on the unit carton (05/18) differs from the date on the bottle label (05/17).
- Brand
Silarx- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Lamivudine Oral Solution is from Lot #0649A and has mismatched expiration dates between the carton and bottle.
Contact Your Pharmacist
Speak with your healthcare provider or pharmacist to determine if you should replace this specific lot of medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for this product?
The National Drug Code (NDC) is 54838-0566-70.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1416-2015 (August 21, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1416-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.